CTIS (Clinical Trial Information System) - Team Specialist

Descripción del puesto:

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

The Opportunity
As a CTIS-team Specialist, you will manage the administration of the EU CTA submission portal, coordinate and support the compilation, completion and submission of EU Clinical Trial Applications (CTAs) and CTA related information, monitor and handle incoming information from regulators and ethics committees with other functions.

This is a one year Fixed term position, were you will be focusing on:
* Creating initial CTAs and handling post-approval activities throughout the CTA lifecycle, including modifications and adding new countries in CTIS.
* Supporting compilation and submission of CTA-related documents following defined processes and guidance from relevant functions.
* Managing and executing submission of CTA-related activities in CTIS and communicating timelines to relevant teams.
* Monitoring CTIS for updates or inquiries from Health Authorities (HAs) or Ethics Committees (ECs), coordinating responses with the relevant functions.
* Tracking and archiving Health Authority inquiries and sponsor responses in internal systems like Veeva Regulatory Information Management.
* Ensuring accuracy and maintaining high-quality records of correspondence while adhering to internal protocols and regulations.
* Assessing automation opportunities, define, test, and roll out process improvements for CTIS management and CTA submission workflows.

Who you are:
● Experience in a similar role or minimum BA or BS (or equivalent) degree in biology, chemistry, pharmacy, or a related field
● Previous experience with regulatory data, documents and dossier structures
(e.g., CTI, CTD) or in the biotech or pharmaceutical industry is beneficial
● Strong communication skills in English (written and spoken) are essential. Additional
languages a plus, based on region/customer requirements
● Ability to communicate clearly and professionally
● Proficiency in a broad range of IT skills
● Data and document management skills
● Attention to detail, especially with respect to data

In Exchange we provide you with:
* Development opportunities: Roche is rich in learning resources. We provide constant development opportunities, free language courses & training, the possibility of international assignments, internal position changes and the chance to shape your own career.
* Excellent benefits & flexibility: Roche Annual Bonus, Monthly transportation allowance, Home Office set - up equipment, Health Insurance, Life/Accident insurance, Full salary when on sick leave for the first 9 days, Eyeglasses settlement, One-time payment options for various events in the life e.g. wedding, childbirth, Service Awards: We value loyalty with additional holidays and bonus payment, Work in a hybrid model (2 days/week from the office)
* A global diverse community, where we learn from each other. At Roche, we cooperate, debate, make decisions, celebrate successes and have fun as a team. Our leadership is very focused on people, creating a strong, inclusive culture, so you always have the chance to share your opinion.

Salary starts from 2400 EUR gross/monthly. Final salary depends on the successful candidate's level of experience, skills and qualifications.

Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an Equal Opportunity Employer